Q3 2022 CTI Biopharma Corp Earnings Call
The conference will begin shortly to raise your hand during Q&A you can dial star one one.
[music].
Yeah.
Good afternoon. Thank you for standing by welcome to C. T I Biopharma third quarter 2022 earnings call. During today's presentation. All parties will be in listen only mode. This conference is being recorded today November 7th.
2022 to ask a question during the session you will need to press star one one on your telephone you will then hear an automated message advising your hand is raised.
I'd now like to turn the conference over to Dr. Adam Craig CEO and President of <unk> Biopharma. Please go ahead.
Thank you Liz and welcome to this afternoon's conference call. Joining me today are David <unk>, Chief Financial Officer, and Jamey phone Chief Commercial officer. Following formal remarks, the conference will be opened for questions before.
Before we begin please note that during this call we will be making forward looking statements based on current expectations.
Statements are within the meaning of the safe Harbor provision of the private Securities Litigation Reform Act of 1995, including but not limited to the types of statements identified as forward looking in our 2021 annual report on Form 10-K that was filed on March 31st 2022 and <unk>.
Subsequent periodic reports filed with the SEC, which are available on our website in the investors section.
Such forward looking statements, which are indicated by terms such as expect intend seek represent our views as of the date of this call.
Not guarantees of future performance and are subject to risks and uncertainties that may cause actual results to differ materially from those anticipated by the forward looking statements, including many that are beyond our control.
These statements include our expectations regarding cash runway market adoption of one Joe on the future success of success of our product launch.
For further description of these and other risks and uncertainties that may cause actual results to differ materially from those expressed in the forward looking statements as well as the risks related to our business. Please see our periodic reports filed with the SEC.
Today, I'm delighted to share our accomplishments with the launch of <unk>, Joe as we work towards becoming the market leader in such Cytopenia myelofibrosis by offering a safe simple and effective therapy for patients with an important medical need.
As a reminder, the FDA approved Vanja, Chris Nib in February for the treatment of adults with myelofibrosis with platelet counts below 50 times 10 to nine per liter.
In the United States at the approximately 21000 patients with myelofibrosis, two thirds have sites peanuts that says thrombocytopenia and anemia, resulting either from disease, a combination toxicity of other approved therapies, such as Rob says isn't it.
Severe thrombocytopenia defined as a blood platelet count below 50 times.
Turning to the nine per liter occurs in one third of the overall population and has a particularly poor prognosis with an overall median survival of just 15 months.
The commercial launch of fungi in United States continues to exceed our internal projections. Today. We are pleased to report $18 2 million in net product revenue for the third quarter, reflecting a 48% increase in sales compared to the second quarter.
<unk> is being actively prescribed to patients with platelet counts less than 50 times 10 to nine per liter and we understand that one Joe has also been used spontaneously in patients with high platelet counts.
The growth in the uptake from Joe has occurred both in the community and academic settings, reflecting growing awareness among health care providers that Juan Jos differentiated from existing MF therapies.
It can be considered as a new standard of care for the treatment of such peanut M. S.
The inclusion of him Joe in the NCC in clinic.
Clinical practice guidelines in oncology for myeloproliferative neoplasms or that is earlier this year as further reinforce Juan Jos mainly for ROE in the treatment of MF.
Medical Affairs team continues to educate health care providers on these guidelines we have one Joe is the only approved JAK inhibitor are recommended by the NCC and regardless of platelet counts.
Over the last six months, we've continued to learn more about the potential mechanisms of action of Undrawn such peanut came out in September at Soho 'twenty. Two we presented new data that showed <unk> to be a highly potent inhibitor of HCV one ACB.
I used to be all one media side and production.
Inhibition is thought to lead to improvements in transfusion independence and anemia in MF patients.
Dallas's demonstrate that treatment with fungi at the approved dose of 200 milligrams twice daily led to improvements in transfusion independence and anemia, when compared to best available therapy in evaluable patients treated in the phase III persist two study.
We've heard from health care providers that clinically meaningful anemia benefit could be an important factor in the decision, making with respect to the treatment of <unk> peanut myelofibrosis.
That's our understanding of this benefit expands we look forward to presenting additional data on this topic during an oral presentation at Ash 2022 next month.
I'll now turn the call over to our Chief commercial officer, Jim <unk> to discuss the highlights of our longevity range Jim.
Thank you Adam as Adam just mentioned, we are pleased to announce $18 2 million in net product revenue for <unk>. This quarter, a 48% growth compared to the second quarter. We are very pleased by the robust uptake of von Joe.
In just our second full quarter of launch and are confident in our ability to deliver strong growth over the coming quarters.
Module is a simple safe and effective new treatment option that addresses the urgent need of existing MF patients are ongoing launch momentum stems from the effective execution of the module launch planned by our sales marketing market access and medical affairs teams, who are deeply committed to making bond Joe the market leader in <unk>.
Myelofibrosis.
Our commercial strategy continues to focus on our three core Vanja launch objectives, one bill module awareness, among myelofibrosis healthcare providers to drive adoption and utilization with our top accounts and high potential prescribers and three ensure optimal patient access via securing effective payer coverage as well.
As our patient support services called CCI access.
Our promotional efforts and activities are driving growth and volatile brand awareness among our target HCP audience. This recent market research studies indicates we have already achieved brand awareness.
To or exceeding and Rebecca which has been on the market for several years.
We continue to invest heavily in peer to peer programs that are designed to educate our ATP is about lanzhou identify the appropriate patients and ultimately support larger demand.
Our field teams have executed approximately 160 peer to peer programs through the end of the third quarter program set it reached more than 1800 hcp's.
This strong HCP participation underscores the broad interest in therapeutic models for myelofibrosis, and more specifically and bond just differentiated clinical value proposition to address the unique needs of these patients.
We are also seeing steady growth in new prescribers, new patients new prescriptions and refills across all lines of therapy in both community and academic settings, approximately 80% of our accounts have reordered vanja multiple times.
Feedback from the field and market research indicate that future prescription growth will result from the early identification of second line sided Phoenix myelofibrosis patients.
With respect to patient access our payer team continues to successfully optimize coverage decisions with payers for module has both commercial and Medicare plans now have approximately 70% and 90% coverage prospectively.
In addition, our patient services team has successfully minimized coverage denials and affordability issues and provided <unk> therapy for those patients waiting for coverage.
The vast majority of patients who are prescribed module receive it.
In summary, I am very pleased with the modules launch progress and growth in the third quarter, we recorded $18 2 million in net revenue.
Reflection of the clear unmet need that exists for site dependent.
Our customers' excitement for Vaughan, just differentiated clinical profile and our team's strong execution in the field.
I will now I will turn the call over to David to review, our quarterly financials David.
Thank you Jim.
Moving on to financial highlights as of September 32022, cash and cash equivalents totaled $81 $6 million as compared to $65 $4 million as of December 31, 2021.
The increase in cash and cash equivalents was primarily attributed to the proceeds received from our aftermarket offering facility and the $60 million payment received from DRA Healthcare Trust that we received upon approval.
This increase strengthens our financial position and extends our cash runway through at least the next 12 months.
Net product sales were $18 $2 million and $32 9 million for the three and nine months ended September 32022, respectively.
Operating loss was $12 $2 million and $23 4 million for the three months ended September 32021, and.
2022, and 2021, respectively.
$66 $2 million and $60 million for the nine months ended September 32022, and 2021, respectively.
Net loss for the three months ended September 32022 was $15 7 million or <unk> 13 for basic and diluted loss per share.
Compared to a loss of $24 2 million or 26 for basic and diluted loss per share for the same period in 2021.
Net loss for the nine months ended September 32022 was $75 million or 69 per basic and diluted loss per share compared to a net loss of 61.
Million or 74.
<unk> basic and diluted loss per share for the same period in 2021.
So with that I will now turn it back to Adam.
Thank you David and thank you Jim So in summary, we're making strong progress with the commercial launch of Hangzhou Guangzhou is a safe simple and effective therapy that is differentiated from existing older therapies.
<unk> ROE is a potent <unk> inhibitor in its clinical benefits on the anemia continues to be studied and we look forward to presenting new data oral presentation at Ash next month.
As our market penetration increases we are successfully moving towards our goal of becoming the market leader in the treatment of <unk>.
That concludes our formal remarks Liz please open the call for questions.
Thank you.
We will conduct the question and answer session.
Minder.
<unk> you will meet.
Our one one on your telephone and wait.
Your name please.
Please standby, while we compile the Q&A roster.
Okay.
Yeah.
My first question.
Question will come from Boris <unk> with Cowen.
Hi, Thank you for taking my question.
Is <unk> <unk>, calling in for <unk>.
Congrats for the strong.
Long quarter again can you comment on that.
Data presented at <unk> and in comparison to the update you gave a quick banner ads.
Additional data will you get a meeting please add to that.
And how should we think about the difference between.
Kenneth and Montana.
Nominal.
Hi, mom in Montana.
Thanks.
Yes, sure well thank you for the questions. So.
The most important component of this data is we've shown for <unk> to be an <unk> inhibitor previously that had not been demonstrated and in fact, the data that will come out to ash shows quite conclusively that where the most potent <unk> inhibitor amongst the JAK inhibitors that are approved.
And we are we will share as four times more potent than moment lots of nib.
So that mechanism then allows us to understand something we've known for one which is that <unk> does have an anemia benefit we published data on this.
In the John masquerading as abstract manuscript that came out in the persist two trial, but what we've looked at recently is the impact of transfusion independence, because that's a very important outcome and thats the outcome.
Sarah oncology used to assess the effects of mine a lot in it and what we found is whilst the data is not collected exactly in analyzing exactly identical ways. We've already shown that we are.
As good as my last name with respect to anemia benefit and that's very important because many of the patients in which we treat with thrombocytopenia, who have thrombocytopenia also have anemia. So we see the data is very important and leveling the playing field with minimal nib and given the fact that we have much better day.
So in the <unk> setting across the board with SVR in TSS rates.
We are we continue to believe that we are and should be the treatment of choice.
For patients with Cytopenia came out.
Yeah.
Next question please.
The next question.
The next question is from Boris <unk> with Cowen Your line is live.
I have asked the question can we go to the next our next one please. Thank you for your question account, but let's move on to the next one please.
Please standby for the next question.
The next question is from Kelly <unk> with Jefferies. Kelly Your line is live.
Thanks, Congrats on a great quarter.
Firstly can you comment at all on Joe's Neil patients started in Q3, and how does it compare to Q2.
Also have follow up.
Yes, so we're not going to give thank you Kelly for your question, Jim is not going to give specific ounces, but he can give general ounces there Jim.
Yes, Hi, yes, we were really encourage I'm really pleased with the growth in new patient starts and we continue to see that as we move on into even this quarter. So we're really really excited about that as physicians gain more experience and confidence with our asset.
Great. Thanks, and also how many days in Q3 were impacted by the recent attempt firsthand the drug price increase and entering Q fall do you expect the seasonality factor due to holidays.
Could have boosted sales from overstocking. Thanks.
I'll answer the first.
So the price increases came in early August .
As you mentioned seasonality, we should say there was some seasonality in this quarter.
And I think that's important to say a lot of the majority of comprehensive <unk> to experience seasonality over the summer months and we did like everyone else Jim your thoughts on seasonality for the rest of the year.
Yes, no doubt that the holiday certainly impact some of the demand is Ah patients don't typically want to go in to see their oncologists, but we believe that the strong growth in new starts and new prescriptions, leading up into the fourth quarter here should carry us through to another strong fourth quarter.
And of course, we Kelly. We also we also have ash, which is a great forum, where we can meet with many of our prescribers and interact with them and share with them.
Our thoughts on the anemia data through the medical affairs team.
Next question please.
Please standby for the next question.
The next question comes from Ken Steel with the Securities. Your line is open.
Hey, guys. Congrats on a great quarter. So I was just wondering if you guys had any color on I guess the degree of off label usage that could be being used inventory as well as maybe any color generally on breakdown between personal lines second Langer potentially third line settings.
Thanks.
Yes, so I'll answer that thanks, Ken it's nice to have you on Nicole we.
As I said I think I've said to you and others the majority of our patients.
Have platelet counts less than 50000, but it's a very significant minority it's not a small number of patients until it's it's a considerable number of patients who are treated spontaneously at the discretion of the treating physician and obviously we cannot promote in the area with respect to first line.
<unk> second line with where we are we thought we would be with respect to first line. The first line population is an incident population. So it takes some time for that.
To that group of patients to grow in our patient mix.
Where we have seen the majority of our patients in a moment as Jim said, it's a very important area of growth for US is in the second line setting because of that prevalent patients.
That continues to be a very high degree of dissatisfaction.
With our reps so they can at particularly low dose rux.
With nib and Thats, an opportunity for us to.
To grow the market in that area.
Yes, Tim I'll, just add other color too as well as the CCN guidelines, obviously gave us a two way recommendation in the second line above 50000, and so we've heard anecdotally in the field as well as in market research that physicians are certainly leveraging the NCC guidelines in that second line above 50000 Skus.
Our product based on their medical adjustment.
Spontaneously.
Okay. Thanks.
Please standby for the next question.
Okay.
Okay.
The next question comes from Bert Hazlett with <unk>.
Your line is open.
Okay.
Thank you. Thank you for taking my question. My first one second one question was just asked I would like to know how you think about the sales force infrastructure and whether it's right size not only for today.
Four.
The arrival of potential additional competition.
In the MLP space.
Thanks, Jamie.
Jim will out critical yep.
Yep.
As you know obviously this is a rare disease.
<unk> had a pretty well defined disease state because of insights work and so we know that there has been approximately 4700 hcp's that treat about over 80% of the patients and about 200 accounts and so we have sized our field force to adequately cover right that that.
Alignment, so we're very comfortable with where we are and certainly adding more people doesn't given the net number of ACP as an account really doesn't make a lot of sense. In addition, we will be the only company solely focus on one asset that sells in the myelofibrosis space, So that will be 100% of our commitment in our in our <unk>.
<unk> of our resources. Unlike other players in this space.
And it's important thank you Jim.
Tim mentioned that we don't with respect to our costs over the coming year, we don't expect a large increase.
Greece, and now cost for sales and marketing because we think the head count will remain.
Very stable there may be a small increase.
An increase for inflation, but we're not anticipating a large increase in sales and marketing costs.
Thank you.
Thank you.
Please standby for the next question.
The next question comes from Ben Burnett with Stifel. Your line is open.
Hey, Thank you very much congrats on the quarter.
If I can I'd like to ask two questions one around the anemia data.
Very interesting data that you put out there, especially at Houston, a few months ago.
Can you talk about what you think it will take for this this data to percolate within the medical community broadly how do you get physicians to sort of broadly recognized ventose anemia benefits.
Or is this already happening.
Yes.
It is.
We cannot promote anemia data, but we can educate and share it through our medical affairs team, which is what we're doing very actively.
Opportunity to sit in an.
The advisory panel, just a week ago, where the ash anemia data was shared confidentially to a group and the reaction is very positive and people are talking about it we should say Ben.
There's no people in the field.
Reported since launch anemia benefit with this drug we hear anecdotally.
And again, so when we share the.
The analysis in persist two in the kinase profile data on ACB all one many of the people we say it just sort of complete.
Link the missing piece of the puzzle when they say it will make sense. So is very well received universally very well received and I as I said in my opening in my remarks, I do think it will become part of the decision making process all of treating physicians.
Honestly, we cannot promote.
We can only educate around the anemia data.
Hey, Ben it's Greg.
The other thing I'll just add to that is.
The original persist few manuscript.
Does outline.
And then even better with <unk>. So our field force right now is able to share that currently from the persist two manuscript the additional analysis from Soho and.
You May ask is what Adam was talking about but just like in our field force is actively out there educating physicians about the anemia benefits that was published in the original persist two manuscripts.
That's very helpful. Thank you and actually Jim if I could also ask you another question.
I think you mentioned earlier that debt.
In terms of payer access or getting giving us access to drug basically you when it gets prescribed it gets.
But.
Maybe just feedback with regards to patients that have platelets above 50000 at baseline is there any color you can provide there in terms of the axis that those patients are getting.
Yes, great question as I mentioned earlier at the NCC guidelines have been very very beneficial for health care providers, who choose to spontaneously use <unk> in that setting about 50000, particularly in the second line and so again, what we've heard anecdotally from the physicians is that the NCC guidelines have been very effective and <unk>.
Prior authorizations and letters of medical necessity approved to the payers and getting coverage for bond Joe above 50000 platelet counts.
Okay. That's great. Thank you very much yeah. Thank you Ben.
Please standby for the next question.
The next question is from Reni Benjamin with JMP. Your line is open.
Hey, good afternoon, guys. Thanks for taking the questions and congratulations on a great quarter.
Maybe I can just start off.
How many accounts.
Have you grown or have reached compared to the last quarter coming into the third and kind of where do you want to be you buyback by the end of the year I think Jim mentioned in his prepared remarks as well.
200 accounts total and reached about 800, HCP as I'm kind of.
I'm trying to follow the trajectory of where we might be by the by the end of this year yes.
Yes, I'll, let Jim answer again as I said earlier, we're not going to give specific numbers today, except for revenue.
The most important thing for us is to grow quarter on quarter and I believe that's what we're doing and that's what we continue to do for next year healthy growth quarter on quarter. I don't think we even began to tap the potential of this drug and I think we've had a good start we're very happy to exceed our internal projections, but growth is what.
We're aiming for I'll, let Jim answer your question, but I don't think he's going to give you any specifics.
Yes, yes, sorry, yes, but we're just know that we're really pleased with both the new prescriber and new accounts.
That are part of that target population, where I just mentioned that have really adopted the product and as I mentioned before the good news that we are seeing multiple orders from 80% of them and so that shows you that theres repeat usage as well as refill is happening. So those are all good signs that we look for a successful launch.
Got it so just sticking with us for a second are there accounts that are not coming onboard and if they're if they're not coming on board.
What are some of the reasons and how do you overcome.
Yes, yes.
Actually we're not seeing that as a big issue all of our key accounts have ordered the product.
As a matter of like we said before getting having the ability to educate them and then gaining experience.
Having a positive experience enough to reorder the product. So it's really we're not that's not a big issue for us we're not concerned about that.
Got it.
Just finally for me as we as we look at kind of the real world application and usage of <unk>, how is it tracking compared to clinical trials.
From a perspective of duration of response, but maybe also from a from a safety perspective is because that was something that was something we had always thought about it yes, let me answer that so we don't have all the data on the how it is tracking because we're only six months through the seven months into the launch but that is something we're looking at.
In my role as interim Chief Medical Officer.
Able to see the safety data the pharmacovigilance data and I'm pleased to say the drug is well tolerated, we've not identified any new signals.
Our any areas of concern. The date is reviewed regularly with the team has reviewed a couple of weeks ago and so far very pleased in the real World I would say the drug is.
Tolerated better than we found in the clinical trials.
Really a reflection of a broader range of patients.
Our clinical trials are pretty specific and who enrolled in a broader population very happy very happy with how how the drug has been tolerated and the safety profile to date.
Yes, Ron congratulations.
Thank you.
Sorry go ahead, Jim I interrupted you.
Oh, no I was just going to say, yes to that point.
We are not seeing those early discontinuation as that happens when the drug is not tolerated that happens in the first few weeks of therapy, we're not seeing that when they discontinue its typically due to progressive disease, because these patients and we're such poor prognosis patient. So that's a great sign for us.
Perfect. Thank you very much and congrats.
Thanks, Ryan Thanks, Jami next question please.
The next question.
The next question comes comes from Gil Blum with Needham Your line is open.
Good afternoon, everyone and let me add my congratulations for a strong quarter.
Thank you.
Okay.
Do you think you guys are going to start.
Providing us with the guidance for sales I mean.
We have a couple of quarters than now.
Yes.
I think next.
I think as we move into next year, we will be able to start providing guidance.
We were only six months into the launch go unless we spoken about.
With you and with others. There is a lot variability at the beginning of the launch, particularly with respect to the GTS.
Finding finding the gross to net number is now stabilizing and I think once it stabilizes and Jim.
<unk> is on a clear trajectory than we can provide some guidance next year.
I don't think we will be providing guidance for the.
The remaining of this year, but certainly in 2023 I think we will.
If if particularly if the <unk> continues to be stable I think thats the biggest variable that we encounter on a weekly basis.
Okay excellent.
One housekeeping question.
You've already noticed that SG&A has gone up maybe.
Maybe a little bit stabilized.
We expect a continuation of drop in R&D expenses.
Gil I think what we're seeing is a stabilizing of the expense run rate in those areas and as we've talked about in the past.
It took a while to build up the commercial infrastructure, including marketing, but it's starting to stable and as we are entering into our budget process. It really is there is no need to expand there will be some costs associated with inflation, but thats the extent of it.
Alright excellent.
I look forward to a strong quarters in the future.
Thank you.
Standby for the next question.
Okay.
The next question is from Thomas Flaten with Lake Street. Your line is open.
Hey, Congrats and thanks for taking the question Adam.
With <unk> coming in the strength of the anemia data that you have in and have you guys considered perhaps rubbished labeling strategy for that may be even elevating one of the tertiary endpoints and Pacific out to a secondary endpoints something like that yes, we are looking at.
We can use the Pacific data to generate.
Anemia benefit data.
But that's still going to be several years away.
The other area, we may be I, together and will be the NCC guidelines.
<unk> revising that guidelines now we do expect them to now we expect them to come out version for the early part next year and then if there is an opportunity to ensuring 'twenty three to include some anemia data, we will submit it and see if it can be included so I think there's two strategies I think the CCN.
Approaches.
Is the one that's most likely to be successful in the shorter term.
Got it.
Just perhaps only anecdotally, but for those low dose rux patients that are being switched over to <unk> is there any consistency and seem as a side effect driven as efficacy driven or are they just.
So overwhelmed by the by the availability of <unk>, they're taking patients off of low dose low dose rux, even if theyre not having any particular issues with it I'm just curious if you could color and some of that I'll, let Jim answer that Jim.
Hi, Thomas Yes, what we're seeing is across the board.
It's the progression.
The disease on logo for us because certainly it is not a proper dose.
Planning is still a problem or symptom is still a problem with a breakthrough that's when they're switching or this tolerability despite them being on low dose rux, we still see accounts going down.
After a while and so so largely it's progressive disease, because the drug is not effective at that dose and or tolerability.
But we are starting to see some physicians who were taking people off because they believe they can get a better response on recruitment and what they're getting now.
And then just one final one if I may.
This idea of Cytopenia myelofibrosis in the co occurrence of thrombocytopenia and anemia, I get that Thats, probably well recognized in the academic centers is that well recognize in the community do you have to do a lot of education, just around that co occur sort of people recognize that.
Just intrinsically.
No Youre right Thomas thought that term and all of that has really been a big driver for us to try to get across and that's why I mentioned the 160 programs. We've already done through the third quarter were largely in the community setting with over 800 Acp's. What we have introduced an educated on Saudi Pinnock myelofibrosis, So youre right its largely already accepted within the academic.
But we're continuing to educate the community providers on this specific part of the disease state and really segmenting the population that's ideal for <unk>.
Excellent thanks for taking the questions.
Thank you Todd.
At this time I would like to turn it back to Dr. Craig <unk> for closing remarks.
Well. Thank you everyone for your for your questions.
Thank you for joining us today, we look forward to our conversations over the coming days weeks and months.
Thank you.
Jason in today's conference. This does conclude the program you may now disconnect.
Okay.
The conference will begin shortly to raise Johan during Q&A you can dial one one.
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